MAUDE Adverse Event Report: SUNEVA MEDICAL, INC. BELLAFILL DERMAL FILLER; IMPLANT, DERMAL, FOR AESTHETIC USE

Model Number	GBF0508
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Ischemia (1942); Necrosis (1971); Pain (1994); Scar Tissue (2060); Obstruction/Occlusion (2422)
Date of Event	03/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Suspected arterial occlusion during bellafill dermal filler injection leading to necrosis caused by the needle hitting the supratrochlear veins in the forehead or suspected vasoconstriction/profound ischemia leading to necrosis caused by mixing of epinephrine with the bellafill dermal filler product.(b)(6) 2021, the patient left a message that they have scabs all over their forehead after injection of the bellafill dermal filler and botox (note, this was later determined to be xeomin, not botox from doctor provided record).The patient believes he will scar.He also relays that he has been to urgent care.There were no responses to attempts to reach the patient until (b)(6) 2021.(b)(6) 2021, the patient responded.He states that the doctor hit a capillary during his bellafill injections on (b)(6) 2021 and there was instant blanching and atrophy at every injection site, there was also pain.The injecting doctor had prescribed nitroglycerin cream and an anti-scarring cream and the scabs are now gone and it is no longer painful, but he states there is also "pimpling" now in the worst areas of scabbing and on his eyelids and his skin is very uneven at this time.He has not gone back to the injector and says he will not.He is trying to find another dermatologist to be evaluated.The patient also provided his medical record information and doctor's progress notes which indicates the patient was injected with 65 units of xeomin and also bellafill dermal filler.The progress notes state: "bellafill loosened with 0.3cc lidocaine 2% with epi.Quickly after very superficial injection of forehead horizontal rhytids developed blanching in the distribution of the supratrochlear artery on the l medial forehead concerning for inadvertent interarterial injection.Nitrol paste > quick improvement.Same thing happened on r and thus concern for epi vasoconstriction > intraarterial injection." the patient relays that he has also contacted the makers of xeomin.(b)(6) 2021, suneva spoke with the injecting doctor, dr.(b)(6).He relays that he mixed the bellafill product with extra lidocaine and also with epinephrine.He relays that he knows this is off-label, but for injections in the forehead with a microcannula he felt it was preferred.He states that while it could be that the supratrochlear artery may have been hit on both sides, he feels it's more likely that the added epinephrine caused vasoconstriction and in this case profound ischemia, resulting in necrosis.He states he did not inject anywhere near the "11s" glabellar area and did not inject at the level which would have contacted the artery.He does not think xeomin was involved in the ae.He believes it was likely the epinephrine caused the vasoconstriction/tissue event leading to necrosis.He says that the patient stopped coming in after (b)(6) 2021.He last heard from the patient on (b)(6) 2021 where the patient relayed that he will not be coming back and is looking for a dermatologist.The bellafill lot number used in the procedure (kit lot f201067) was evaluated and no issues were noted in manufacturing records or in retained samples.The suspected root cause is off-label use.Per the bellafill instructions for use (ifu): bellafill dermal filler is indicated for the correction of nasolabial folds and moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years.In addition, the bellafill ifu cautions against mixing bellafill with other products: "bellafill® should not be mixed with other products before implantation of the device." the bellafill ifu also provides the following warning "introduction of product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction.Take extra care when injecting soft-tissue fillers; for example, inject the product slowly and apply the least amount of pressure necessary.Rare but serious adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment; blindness; cerebral ischemia; or cerebral hemorrhage, leading to stroke, skin necrosis, and damage to underlying facial structures.Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure.Patients should receive prompt medical attention and possibly evaluation by an appropriate health care practitioner specialist should an intravascular injection occur." bellafill syringes are single use devices and are typically discarded after use.Per the bellafill ifu: "the syringe and any unused material should be discarded after a single treatment visit.".
Event or Problem Description
Suspected arterial occlusion during bellafill dermal filler injection leading to necrosis caused by the needle hitting the supratrochlear veins in the forehead or suspected vasoconstriction/profound ischemia leading to necrosis caused by mixing of epinephrine with the bellafill dermal filler product.

• Brand Name: BELLAFILL DERMAL FILLER
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): SUNEVA MEDICAL, INC.; 5870 pacific center blvd.; san diego CA 92121
• MDR Report Key: 11816346
• Report Number: 3003707320-2021-00004
• Device Sequence Number: 3910948
• Product Code: LMH
• UDI-Device Identifier: 10350224000025
• UDI-Public: (01)10350224000025(17)220426(10)F201067
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2022
• Device Model Number: GBF0508
• Device Catalogue Number: GBF0508
• Device Lot Number: F201067
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EPINEPHRINE ADDED TO BELLAFILL BY PHYSICIAN.; EXTRA LIDOCAINE ADDED TO BELLAFILL BY PHYSICIAN.; XEOMIN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability